Viewing Study NCT05633251


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Study NCT ID: NCT05633251
Status: COMPLETED
Last Update Posted: 2022-12-01
First Post: 2020-12-27
Is NOT Gene Therapy: True
Has Adverse Events: False

Brief Title: Using Reinforcement Schedules to Increase Fruit&Vegetable Intake, Reduce Waste, and Increase School Lunch Participation
Sponsor:
Organization:

Raw JSON

{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D011897', 'term': 'Random Allocation'}], 'ancestors': [{'id': 'D015340', 'term': 'Epidemiologic Research Design'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D012107', 'term': 'Research Design'}, {'id': 'D008722', 'term': 'Methods'}, {'id': 'D017531', 'term': 'Health Care Evaluation Mechanisms'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}, {'id': 'D011634', 'term': 'Public Health'}, {'id': 'D004778', 'term': 'Environment and Public Health'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT'], 'maskingDescription': 'Participants were not aware of the purpose of the intervention.'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': 'Number of participants below is best estimate of students exposed to the intervention based on school lunch participation rates.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1626}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-09-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-11', 'completionDateStruct': {'date': '2016-05-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-11-28', 'studyFirstSubmitDate': '2020-12-27', 'studyFirstSubmitQcDate': '2022-11-28', 'lastUpdatePostDateStruct': {'date': '2022-12-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-12-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-05-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in food waste', 'timeFrame': '24 weeks', 'description': 'Daily fruit, vegetable, and other food waste (in lbs)'}, {'measure': 'Change in fruit and vegetable intake', 'timeFrame': '12 weeks', 'description': 'As measured by carotenoid level, a biomarker for total fruit and vegetable intake; measured before and after the intervention'}], 'secondaryOutcomes': [{'measure': 'School lunch participation rates', 'timeFrame': '32 weeks', 'description': 'Number of participants in the school lunch program'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['fruit, vegetable, food waste'], 'conditions': ['Behavioral Changes', 'Psychology, Social', 'Nutrition']}, 'descriptionModule': {'briefSummary': 'Using small monetary rewards to reinforce healthy behaviors, such as the consumption of fruits and vegetables (F\\&V), the investigators tested fixed and variable reinforcement schedules in three middle schools.\n\nThe investigators measured carotenoid levels, as a biomarker of F\\&V intake, and F\\&V waste over the intervention time frame. The investigators also tracked the school lunch participation rates over time.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '16 Years', 'minimumAge': '11 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* students attending three participating middle schools (Ysleta Independent School District)\n\nExclusion Criteria:\n\n* N/A'}, 'identificationModule': {'nctId': 'NCT05633251', 'briefTitle': 'Using Reinforcement Schedules to Increase Fruit&Vegetable Intake, Reduce Waste, and Increase School Lunch Participation', 'organization': {'class': 'OTHER', 'fullName': 'New Mexico State University'}, 'officialTitle': 'Using Reinforcement Schedules to Improve Carotenoid Levels, Reduce Fruit and Vegetable Waste, and Increase School Lunch Participation in El Paso', 'orgStudyIdInfo': {'id': '12335 & 12324'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'School 1', 'interventionNames': ['Behavioral: Variable (non-random) interval', 'Behavioral: Control']}, {'type': 'EXPERIMENTAL', 'label': 'School 2', 'interventionNames': ['Behavioral: Variable (random) interval', 'Behavioral: Control']}, {'type': 'EXPERIMENTAL', 'label': 'School 3', 'interventionNames': ['Behavioral: Variable (random) interval', 'Behavioral: Variable (random) interval with table tents']}], 'interventions': [{'name': 'Variable (random) interval', 'type': 'BEHAVIORAL', 'description': 'Using Variable (Random) Interval Reinforcement Schedules to Increase Fruit and Vegetable Intake, Reduce Fruit and Vegetable Waste, and Increase School Lunch Participation', 'armGroupLabels': ['School 2', 'School 3']}, {'name': 'Variable (non-random) interval', 'type': 'BEHAVIORAL', 'description': 'Using Variable (Non-random) Interval Reinforcement Schedules to Increase Fruit and Vegetable Intake, Reduce Fruit and Vegetable Waste, and Increase School Lunch Participation', 'armGroupLabels': ['School 1']}, {'name': 'Variable (random) interval with table tents', 'type': 'BEHAVIORAL', 'description': 'Using Variable (Random) Interval Reinforcement Schedules and Table Tents with Health-related Messages to Increase Fruit and Vegetable Intake, Reduce Fruit and Vegetable Waste, and Increase School Lunch Participation', 'armGroupLabels': ['School 3']}, {'name': 'Control', 'type': 'BEHAVIORAL', 'description': 'No intervention', 'armGroupLabels': ['School 1', 'School 2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '79925', 'city': 'El Paso', 'state': 'Texas', 'country': 'United States', 'facility': 'Ysleta Independent School District', 'geoPoint': {'lat': 31.75872, 'lon': -106.48693}}], 'overallOfficials': [{'name': 'Mihai Niculescu, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'New Mexico State University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'New Mexico State University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Paso del Norte Health Foundation', 'class': 'OTHER'}, {'name': 'University of Texas', 'class': 'OTHER'}, {'name': 'Brigham Young University', 'class': 'OTHER'}, {'name': 'Ysleta Independent School District, El Paso', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor of Marketing', 'investigatorFullName': 'Mihai Niculescu', 'investigatorAffiliation': 'New Mexico State University'}}}}